OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns
This article was originally published in The Pink Sheet & The Rose Sheet
Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.
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The length of exclusivity periods is the only major difference between pending US House and Senate bills, both largely based on a proposal developed by FDA and drug industry representatives. Committees in both chambers are expected to vote on moving the bipartisan proposals to floor votes within two months.
FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn’t implement changes.
FDA schedules a public meeting June 10 and opens a docket for stakeholder input on the potential development of a user fee program for OTC monograph drugs. CDER points out the OTC monograph is "one of the largest and most complex regulatory programs ever undertaken at FDA."